Strategies for Transfusion of Platelets (SToP)

NCT00420914 | Terminated Phase 3

• 1 other identifier: SToP Study
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 6

Brief Summary

To evaluate the hemostatic efficacy of a low dose platelet transfusion strategy compared to a standard dose platelet transfusion strategy.

Conditions

Thrombocytopenia

Keywords

Thrombocytopenia; Platelets; Dose; Bleeding

Outcome Measures

Primary Outcomes (1)

• Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.

Secondary Outcomes (19)

• Number of platelets transfused during a defined period of thrombocytopenia

• Number of platelet transfusion events(frequency)

• Number of platelets transfused and frequency per thrombocytopenic day

• Mean duration of thrombocytopenia

• Percentage of days at risk of bleeding

Interventions

low dose of 2.25 x 10^11 platelets/transfusion (range 1.5 to 2.9) PROCEDURE

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hypoproliferative thrombocytopenia who are expected to have a platelet count of ≤ 10,000/µL (10x10\^9/L) for ≥ 10 days (Note: the prophylactic platelet trigger may be higher than10,000/µL (10x10\^9/L) in some participating institutions; however, the patient will still be eligible for participation as long as they are expected to be thrombocytopenic for 10 days)
• Must be an inpatient.
• Weight between 40 and 100 kg.

You may not qualify if:

• Diagnosis of promyelocytic leukemia.
• A history or current diagnosis of immune thrombocytopenia (ITP), thrombotic thrombocytopenia (TTP), or hemolytic uremia syndrome (HUS).
• Evidence of ≥ WHO Grade 2 bleeding while being assessed for the study entry.
• Patients who will receive bedside Leukoreduced platelet transfusions.
• Patients who are pregnant.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Dartmouth-Hitchcock Medical Center: collaborator
• Haukeland University Hospital: collaborator
• Ottawa Hospital Research Institute: collaborator
• Cedars-Sinai Medical Center: collaborator
• University Health Network, Toronto: collaborator

Study Sites (6)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Location

Ottawa Health Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network

Toronto, Ontario, M5G2M9, Canada

Location

Haukeland University Hospital

Bergen, Norway

Location

Related Publications (1)

• Heddle NM, Cook RJ, Tinmouth A, Kouroukis CT, Hervig T, Klapper E, Brandwein JM, Szczepiorkowski ZM, AuBuchon JP, Barty RL, Lee KA; SToP Study Investigators of the BEST Collaborative. A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia. Blood. 2009 Feb 12;113(7):1564-73. doi: 10.1182/blood-2008-09-178236. Epub 2008 Dec 24.

  PMID: 19109560 DERIVED

MeSH Terms

Conditions

Thrombocytopenia; Hemorrhage

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Nancy M Heddle, MSc., FCSMLS(D)

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 11, 2007
• Study Start: October 1, 2003
• Last Updated: May 28, 2008

Record last verified: 2008-05

Locations

CA (3); NO (1); US (2)